Heart Failure and Sudden Cardiac Death Japan Registry

Heart Failure Clinical Trial

— HINODE  

Official title:

Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185832
• Other study ID #: C2076
• Status: Completed
• Start date: July 21, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be compared with available published data mainly from Europe and the United States.

Selected Subject Cohorts:

1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment.

2. Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-Defibrillator (CRT-D) device treatment.

3. Selected subject cohort who are clinically expected to require >40% right ventricular pacing with a left ventricular ejection fraction (LVEF) ≤50%, any determined New York Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades).

4. Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF ≤35%, having 2 to 5 predefined SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D, PM, or CRT-P.

The primary endpoint will report on the Composite rate of first appropriately treated ventricular arrhythmia (by anti-tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions in a study population with a majority of Japanese subjects. This primary end point is assessed in the ICD/CRT-D implanted patient cohort.

The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data) will be assessed in the Pacing (PM/CRT-P) patient cohort.

The all-cause mortality will be assessed in the non-implanted subject cohort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

General Inclusion Criteria:

1. Subject is aged 20 or above

2. Subject is willing and capable of providing informed consent

3. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigation Plan (CIP)

4. Measured Ejection fraction value obtained by echocardiography or equivalent method as Standard of Care (SOC):

• Device cohorts: within the last 3 months prior to enrolment

• Non-device cohort: latest available within the last 12 months prior to enrollment in case there was no documented HF decompensation, myocardial infarction (MI) or revascularization, otherwise within the last 3 months prior to enrollment

And 12 lead electrocardiogram (ECG) recording available as SOC:

• Device cohorts: pre-implant ECG maximum 45 days before implant; post-implant ECG

• Non-device cohort: latest available maximum 12 months prior to enrollment and subject agrees in the data being used for this study

General Exclusion Criteria:

1. Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:

• Schedule of procedures for the HINODE Study (i.e. should not cause additional or missed visits)

• HINODE Study outcome

• Conduct of the HINODE Study per Good Clinical Practice /International Standard Organization 14155:2011/local regulations as applicable

2. Device implant revision is scheduled due to unstable result of an implant <45 days prior enrolment

3. Subjects with more than 5 of the following risk factors: LVEF <35%, NYHA Class III or IV, left bundle branch block (LBBB) with QRS > 130 ms or QRS =150 ms, renal dysfunction (chronically BUN >26 mg/dL / =9.28 mmol/L), diabetes type I and II, chronic atrial fibrillation (permanent or persistent according to ESC Guideline 2016), prior MI, age >70 years, smoking today or during last 5 years

4. Subjects with chronic renal disease with chronic BUN =50mg/dL or creatinine =2.5 mg/dL

5. Subjects with coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within the past three calendar months prior to enrollment

6. Subjects with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment

7. Subjects who are expected to survive for <1 year with good functional status

8. Subject's physician does not allow participation

9. Subject is not willing and capable of participating in all testing or visits associated with this clinical study at an approved clinical study center and at the intervals defined by this CIP

10. Unwilling to sign the consent for participation

11. Women of childbearing potential who are or might be pregnant at the time of study enrolment

12. ICD and CRT-D cohorts: implanted with a non-BSC device system. PM/CRT-P cohorts:

implanted with a non-BSC pulse generator device.

Additional eligibility criteria apply to each cohort

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Intervention

Device:
• CRT-D
This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities
• ICD
This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities
• PM / CRT-P
This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities

Other:
• Non-device
Patient enrolled but not implanted with a Defibrillator or Pacemaker

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital	Amagasaki	Hyogo
Japan	Nippon Medical School Hospital	Bunkyo	Tokyo
Japan	Tokyo Medical and Dental University Medical Hospital	Bunkyo	Tokyo
Japan	St. Luke's International Hospital	Chuo	Tokyo
Japan	Kokura Memorial Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Hyogo Brain and Heart Center	Himeji	Hyogo
Japan	Hitachi General Hospital	Hitachi	Ibaraki
Japan	Ichinomiya Municipal Hospital	Ichinomiya	Aichi
Japan	Fukuoka Tokushukai Hospital	Kasuga	Fukuoka
Japan	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa
Japan	Toho University Ohashi Medicine Center	Meguro	Tokyo
Japan	Japanese Red Cross Nagoya Daini Hospital	Nagoya	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Okayama University Hospital	Okayama
Japan	Osaka General Medical Center	Osaka
Japan	Sakurabashi Watanabe Hospital	Osaka
Japan	Toho University Omori Medical Center	Ota	Tokyo
Japan	Japanese Red Cross Saitama Hospital	Saitama
Japan	Jichi Medical University Saitama Medical Center	Saitama
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo	Hokkaido
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Tokyo Metropolitan Hiroo Hospital	Shibuya	Tokyo
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	National Cerebral and Cardiovascular Center Hospital	Suita	Osaka
Japan	Osaka University Hospital	Suita	Osaka
Japan	University of Tsukuba Hospital	Tsukuba	Ibaraki
Japan	Yamaguchi University Hospital	Ube	Yamaguchi
Japan	Juntendo University Urayasu Hospital	Urayasu	Chiba
Japan	St. Marianna University School of Medicine, Yokohama City Seibu Hospital	Yokohama	Kanagawa
Japan	Yokohama Minami Kyousai Hospital	Yokohama	Kanagawa
Japan	Yokohama Rosai Hospital	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	ICON Clinical Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts	Number of Participants with first appropriately treated ventricular arrhythmia (by anti tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT Arm B or C programming conditions in a study population with a majority of Japanese subjects.	12 months follow up
Primary	Number of Participant Deaths - Pacing Cohort	All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data).	12 months follow up
Primary	Number of Participant Deaths - Non-Device Cohort	All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors.	12 months follow up
Secondary	Number of Participant Deaths - ICD/CRT-D Cohorts	All-cause mortality for the ICD and the CRT-D cohorts.	12 months follow up
Secondary	Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts	Number of Participants with HF events, which require intravenous (IV) treatment and/or heart failure (HF) related hospitalization, or which led to HF death	12 months follow up
Secondary	Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts	Complication refers to qualified serious adverse device effects (SADEs) post success implantation, such as re-implant procedure, required invasive procedure related to the device system, pacing exit block, all-cause infection, and death due to therapy failure.	12 months follow up